Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365989
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2006-08-17
Brief Title:
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication
Detailed Description:
Uterine leiomyoma fibroids are the most common neoplasms of the female pelvis These benign tumors are generally oval in shape and often highly vascular On T2 weighted MR imaging exams or T1 exams with contrast uterine fibroids are easily identifiable They occur in 20-25 of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid InSightec has developed an Enhanced Sonication ES technique for the ablation of these fibroids This mode of tissue ablation has been added to the already FDA approved ExAblate system The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None